Monoclonal Antibody

RegulatoryAugust 6, 2026

FDA grants priority review for BLA761352 (ZENOCUTUZUMAB-ZBCO) by Merus N.V.

The FDA has granted priority review status for the supplemental biologics application BLA761352 for ZENOCUTUZUMAB-ZBCO.

CompetitiveAugust 1, 2026

First-in-Human Trial for GSK4425689A Monoclonal Antibody Initiated

A first-in-human dose-escalation study for GSK4425689A is underway, focusing on safety and pharmacokinetics.

StrategyJuly 30, 2026

FDA Approves LYTENAVA (BLA761320) from Outlook Therapeutics

The FDA has approved LYTENAVA (BLA761320), a new formulation of Bevacizumab by Outlook Therapeutics.

ClinicalJuly 29, 2026

Phase I Trial of GR2301 Injection by Genrix Initiated in Healthy Adults

Genrix has initiated Phase I clinical trial for GR2301 injection to assess its safety and pharmacokinetics in healthy adults.

RegulatoryJuly 29, 2026

FDA Approves LYTENAVA (BLA761320) for Use

The FDA has approved LYTENAVA, a new formulation of bevacizumab, under application BLA761320.

ClinicalJuly 25, 2026

Phase 1 Trial of M3T01 Monotherapy and Combination Therapy in Solid Tumors

A Phase 1 first-in-human trial is underway to evaluate M3T01, a monoclonal antibody targeting FasL, in patients with metastatic or unresectable solid tumors.

RegulatoryJuly 21, 2026

FDA Accepts Supplement Application for DARZALEX (Daratumumab)

The FDA has accepted a supplemental application for DARZALEX (daratumumab) from Janssen Biotech.

RegulatoryJuly 20, 2026

FDA Grants Priority Review for ABBVIE's BLA761460 (DECNUPAZ)

The FDA has granted priority review for ABBVIE's Biologics License Application for DECNUPAZ (BLA761460).

ClinicalJuly 20, 2026

Genmab's GEN1042 Trial Evaluates Anti-tumor Activity in Solid Tumors

The trial aims to assess the safety and anti-tumor activity of GEN1042, both as a monotherapy and in combination with pembrolizumab.

RegulatoryJuly 15, 2026

FDA Accepts Application for SARCLISA (Isatuximab-IRFC) by Sanofi

The FDA has accepted the Biologics License Application for SARCLISA (Isatuximab-IRFC) from Sanofi.

RegulatoryJuly 12, 2026

FDA Grants Priority Review for TRUTAKNA (BLA761486) by Vera Therapeutics

The FDA has granted priority review status for TRUTAKNA, an application submitted by Vera Therapeutics.

ClinicalJuly 9, 2026

Procizumab shows safety and tolerability in first-in-human trial for cardiogenic shock

Procizumab (PCZ) demonstrated mild adverse events and no serious safety concerns in Phase 1 trial with healthy volunteers.

RegulatoryJuly 8, 2026

FDA Approves Supplemental Application for TRUXIMA (Rituximab-ABBS)

The FDA has approved a supplemental application for TRUXIMA, a biosimilar to Rituximab, developed by Celltrion.

ClinicalJuly 6, 2026

First Human Study of SBT777101 in Rheumatoid Arthritis by Sonoma Biotherapeutics

Sonoma Biotherapeutics is conducting the first human trial of SBT777101 for rheumatoid arthritis, focusing on safety and effects.

RegulatoryJuly 3, 2026

FDA Approves Supplemental Application for SARCLISA (Isatuximab-IRFC)

The FDA has approved a supplemental application for SARCLISA, a monoclonal antibody targeting CD38.

RegulatoryJuly 3, 2026

FDA Approves BLA761530 (LUMVOA) from Viridian Therapeutics

The FDA has approved BLA761530, known as LUMVOA, submitted by Viridian Therapeutics.

RegulatoryJuly 1, 2026

FDA Accepts Supplement for SARCLISA (Isatuximab-IRFC) by Sanofi

The FDA has accepted a supplemental application for SARCLISA, a monoclonal antibody targeting CD38.

RegulatoryJune 22, 2026

FDA Grants Priority Review for Pfizer's Marstacimab (BLA761369)

The FDA has granted priority review status for Pfizer's BLA761369, containing the active ingredient Marstacimab.

ClinicalJune 22, 2026

AbCellera initiates Phase 1 trial for ABCL575 assessing safety in healthy participants

AbCellera Biologics has launched Phase 1 trial to evaluate the safety and tolerability of ABCL575 in healthy volunteers.

RegulatoryJune 21, 2026

FDA Grants Priority Review for Pfizer's Marstacimab (HYMPAVZI) Supplement

The FDA has granted priority review status for the supplemental application of Marstacimab (HYMPAVZI) by Pfizer.

RegulatoryJune 20, 2026

FDA Accepts Supplement Application for DARZALEX by Janssen Biotech

The FDA has accepted the supplemental application for DARZALEX (daratumumab) from Janssen Biotech.

ClinicalJune 20, 2026

Ravulizumab Shows Promise in Reducing Delayed Graft Function in Kidney Transplant Patients

A clinical trial is evaluating the efficacy of ravulizumab in reducing delayed graft function (DGF) in kidney transplant patients.

Companies

Assets

Recent signals(22)